Kornimate/medical-research-clean huggingface dataset:
tranexamic acid to improve same-day discharge rates after holmium laser enucleation of the prostate (holep)

Conditions: Kidney Calculi; Urologic Diseases; Benign Prostatic Hypertrophy

Summary: this study is designed to assess if there is a significant difference in same day discharge rates after holmium laser enucleation of the prostate (holep). the investigators attempt to perform holep as a same-day discharge (sdd) procedure, but at northwestern memorial, the sdd rate is currently approximately 60%. the limiting factor in sdd is hematuria. tranexamic acid (txa) is a clot promoting drug that is commonly used by orthopedic, cardiac and obstetric surgeons to prevent bleeding. the primary outcome will be to assess if there is a difference in sdd rates in those who receive txa vs. those who do not. secondary outcomes will assess bleeding complications (defined as unplanned ed visit/clinic visit/procedure/admission related to bleeding, clot retention, clot evacuation, need for perioperative transfusion) between participants who receive txa vs. those do not. the study will also assess differences in perioperative complications associated with txa including but not limited to: deep venous thrombosis, pulmonary embolism, cerebrovascular events, between the groups. the study will also assess for the duration of postoperative hematuria between groups as well as differences in operative times between the groups. the investigators anticipate that there may be up to a 25% increase in sdd rates in those who receive txa vs. those who do not.

on the day of the surgery, the treatment assigned to the participant will be determined by chance, like flipping a coin. one arm will undergo the holep procedure while receiving 1g txa iv intraoperatively. the second arm will undergo the holep procedure without receiving txa iv intraoperatively. after surgery, participants will receive weekly surveys via text message or email asking them to report any instances of difficulty urinating or blood in the urine. these surveys will continue for 12 weeks. 30 days after surgery, participants will come in for a standard clinical follow up appointment where they will be asked to complete a questionnaire about bleeding complications and symptoms. 12 weeks after surgery, participants will come in for their 12-week follow up and will be assessed for benign prostate hyperplasia (bph) symptoms and their urine flow rate will be measured.

Eligibility criteria:
inclusion criteria: * males 18-89 undergoing holep * willing to sign the informed consent form * able to read, understand, and complete patient questionnaires, pain texts, and medication diary exclusion criteria: * allergy or hypersensitivity to txa, history of acute venous or arterial thrombosis, intrinsic risk for thrombosis or thromboembolism, history of thromboembolic disease, hereditary thrombophilia, use of hormonal agents * patients having any additional simultaneous procedure other than a holep (cystolitholapaxy allowed). * anticipated need for perineal urethrostomy at the time of holep * patient not undergoing catheter removal and voiding trial at northwestern memorial hospital
effects of physical training and nutrition education on adipocytokines in severely obese teenagers

Conditions: Healthy; Obesity

Summary: obesity is now becoming significantly prevalent of an environment characterized by easily available calorics foods combined with sedentary lifestyles. moreover, it has been demonstrated that obesity is associated with metabolic complications such as disturbed adipocytokines, hormones secreted by adipose tissue. given these observations, the purpose of this study is to assess the effects of a lifestyle intervention focused on various physical activities and nutrition education on adipocytokines hormones, in severely obese teenagers.


Eligibility criteria:
inclusion criteria: * to be aged from 12 to 17 * to have a body mass index \> 97 percentile for age and gender exclusion criteria: * systemic disease * endocrine disorder * syndromic obesity * subjects receiving medication with a history of recent intercurrent illness

Keywords: childhood obesity adipocytokines physical exercise nutrition education
comparison of success rates of femoral artery catheterization

Conditions: Pulmonary Disease; Electrolyte Disorder; Metabolic Disease; Sepsis

Summary: the use of usi has eased practical application of interventional procedures, and reduced complications and procedure durations. for vascular interventions with ultrasound imaging, short- or long-section imaging of vascular structures is performed. both techniques have their own advantages and disadvantages. this study aims to compare the success rates of femoral artery catheterization using both imaging techniques.

the research will include newborns undergoing open heart surgery and patients requiring arterial monitoring in the neonatal intensive care unit. eighty patients requiring femoral artery cannulation will be randomized with the closed envelope method and separated into two groups as usi with the in-plane technique (group a) and usi with the out-of-plane technique (group b). the intervention will be performed by a single experienced individual. the preparation duration, puncture duration, number of punctures, number of unsuccessful arterial punctures, development of hematoma and other complications will be recorded and the groups will be compared. if there are 3 unsuccessful attempts the procedure will be ended.1. patients undergoing kvc surgery and patients requiring arterial catheterization in the neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic disease, or sepsis requiring frequent blood sampling) exclusion criteria for study volunteers 1. local infection 2. coagulopathy clinical end-points (measured variables) 1. distance of femoral artery to skin, distance of femoral artery to inguinal ligament, femoral artery diameter, femoral artery and vein location properties 2. preparation duration, number of punctures, complications developing during the procedure

Eligibility criteria:
inclusion criteria: * patients undergoing kvc surgery and patients requiring arterial catheterization in the neonatal intensive care unit (cases with pulmonary disease, electrolyte disorders, metabolic disease, or sepsis requiring frequent blood sampling exclusion criteria: 1. local infection 2. coagulopathy

Keywords: newborns,femoral artery, catheterization
popliteal nerve block for postoperative pain control in ankle and hindfoot reconstruction

Conditions: Pain, Postoperative

Summary: the purpose of this study is to evaluate outcomes of popliteal nerve blocks for postoperative pain control in patients undergoing ankle and hindfoot reconstruction surgeries. the following outcomes will be analyzed: length of hospital stay, level of pain control, pain medication use, complications, and patient satisfaction.


Eligibility criteria:
inclusion criteria: * adult patients ≥ 18 years old * patients undergoing ankle, subtalar, pantalar, triple, or tibiotalocalcaneal arthrodesis (cpt codes 27870, 28715, 28725, or 28740) * patients undergoing total ankle arthroplasty (cpt code 27702) * patients with a preoperative surgical plan to receive a popliteal nerve block during the postoperative period * patients whom can be reasonably expected to understand and comply with patient-reported postoperative data collection and surveys exclusion criteria: * patients undergoing an ankle or hindfoot reconstruction procedure whom are medically ineligible to receive a safe popliteal nerve block (i.e. patients with neuropathy) * patients with documented substance abuse (i.e. history of narcotic abuse could confound pain outcomes)

Keywords: nerve block ankle talus pain, postoperative
virtual reality based balance training in people with mild cognitive impairment

Conditions: Distorted; Balance; Motor Deficit; Cognitive Deficit

Summary: the aim of the present study is to evaluate an innovative virtual reality-based balance training intervention for improving clinically relevant motor performances (balance and gait) in people with mild cognitive impairment. the investigators hypothesize that the virtual reality-based balance training intervention will improve balance and gait performances in people with mild cognitive impairment compared to a control group receiving usual care only.


Eligibility criteria:
inclusion criteria: * diagnosis of mild cognitive impairment * willingness to provide informed consent exclusion criteria: * severe neurologic, cardiovascular, metabolic, or psychiatric disorders * severe visual impairment * severe cognitive impairment * dementia
a study of tak-994 in adults with narcolepsy

Conditions: Narcolepsy Type 1 (NT 1)

Summary: adults with narcolepsy who have completed the tak-994-1501 study will be able to take part in this study. the main aim of this study is to check if participants have side effects from tak-994. participants will take one of 3 different tak-994 dose for 8 weeks. then, half the participants will continue with their dose of tak-994 and half will take a placebo. in this study, a placebo will look like a tak-994 tablet but will not have any medicine in it. participants will take tak-994 or placebo for 4 weeks. participants will visit the clinic for a final check-up 2 weeks after their last dose of tak-994 or placebo. the study doctors will check for side effects from tak-994 and placebo throughout the study. participants will continue to record any narcolepsy symptoms as they did in part b of the tak 994-1501 study.

the drug being tested in the study is called tak-994. tak-994, is being tested to treat participants with nt1. participants who completed part b of tak-994-1501(nct04096560) will be eligible for enrollment in this study. this study will enroll approximately 112 patients to receive one of three different tak 994 dose for 8 weeks (active drug extension period). participants will be randomly assigned to one of these different tak 994 doses which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). following the 8-week active drug extension period, participants will continue into a 4-week double-blind randomized withdrawal period and will receive tak-994 or placebo. participants randomized to tak-994 will continue to receive the same dose as before. this multi-center trial will be conducted worldwide. the duration of treatment in this study is 12 weeks plus a 2 week safety follow up period. participants will visit the clinic 10 times after the first dosing.

Eligibility criteria:
inclusion criteria: 1. participant with a diagnosis of narcolepsy type 1 (nt1) who has completed tak-994-1501 part b before enrollment (which will occur immediately following the final tak-994-1501 assessments), and for whom the investigator has no clinical objection they be enrolled. exclusion criteria: 1. participant has a clinically significant moderate or severe ongoing ae related to the study drug from the prior study.

Keywords: drug therapy
4d-flow mri to assess left ventricular obstruction in hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy; Obstruction; Echocardiography

Summary: hypertrophic cardiomyopathy (hcm) is a frequent cardiac pathology with an estimated prevalence of 1/500 in france. the main risk factor for sudden death in this pathology is the presence and extent of left ventricular obstruction. to date, the only method allowing a reliable assessment of the extent of left ventricular obstruction is doppler echocardiography. all patients with hcm should undergo cardiac magnetic resonance imaging (mri) to confirm the diagnosis and for the detection of fibrosis, but conventional sequences cannot reliably assess the obstruction. 4d-flow mri provides a complete coverage of an entire volume with the ability to simultaneously measure the outputs of all vessels within that volume in a single sequence and might be able to quantify left ventricular obstruction. the main objective of this study is to compare the quantification of left ventricular obstruction in hypertrophic cardiomyopathy by doppler echocardiography and 4d flow mri.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * presence of a hypertrophic cardiomyopathy (hcm) * affiliation to a social security program * ability of the subject to understand and express opposition exclusion criteria: * major obesity (\> 140 kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70cm, * age \< 18, * person under guardianship or curators, * pregnant woman, * allergy to gadolinium chelates, * claustrophobia, * any contraindications to mri

Keywords: hypertrophic cardiomyopathy 4d-flow magnetic resonance imaging obstruction maximal gradient echocardiography
dermal cryotherapy for treatment of pigmented lesions

Conditions: Pigmented Skin Lesion

Summary: study to evaluate the ability of the dermal cooling system to reduce pigmentation in benign pigmented lesions.

this study is a prospective, non-randomized, multi-center study of the dermal cooling system to verify that the device causes a reduction in pigmentation in benign pigmented lesions, and to determine at what parameters the device is most effective.

Eligibility criteria:
inclusion criteria: 1. male or female subjects \> 18 years of age. 2. subject has one or more benign pigmented lesions (e.g., solar lentigines, melasma, freckles, café au lait, nevi, or hyperpigmentation), in an area suitable for treatment 3. subject is willing to have up to 40 treatment sites and/or an area up to 8 square inches treated depending on the size and nature of the lesions identified. 4. subject is willing to have digital photographs taken of the treatment area and agrees to use of photographs for presentation, educational, or marketing purposes. 5. subject is willing to cover treated area or have very limited sun exposure and use an approved sunscreen of spf 50 or higher on the treated areas for the duration of the study, including the follow-up period, if requested. 6. subject has read and signed a written informed consent form. exclusion criteria: 1. physician prescribed medical or surgical treatment, or use of over-the-counter products to alter skin color, in the area of intended treatment in the previous 6 months (e.g., hydroquinone, corticosteroids, laser surgery) 2. artificial tanning in the area of intended treatment within 1 month (e.g., spray, lotion, tanning bed) or intention to use artificial tanning within the follow-up period 3. scars or tattoos in the location of the treatment sites 4. history of vitiligo, eczema, or psoriasis in the area of treatment 5. history of melanoma 6. known history of illness or adverse reaction to cold insult (e.g., cryoglobulinemia, cold urticaria, paroxysmal cold hemoglobinuria, reynaud's disease. 7. history of abnormal wound healing or abnormal scarring 8. inability or unwillingness to comply with the study requirements. 9. current enrollment in a clinical study of any other unapproved investigational drug or device. 10. any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.
the ultrasound-guided vs bronchoscopy-guided vs ultrasound-bronchoscopy-guided percutaneous tracheostomy trial

Conditions: Tracheostomy Complication; Tracheostomy Infection; Tracheostomy Hemorrhage

Summary: this trial (broncus) is a randomized one designed to evaluate the overall safety of ultrasound guided compared to bronchoscopy guided compared to ultrasound-bronchoscopy guided percutaneous tracheostomy, in order to find out if universal standardization is required or customized approach can be sufficient.

enrolled patients will be randomized in a 1:1:1 ratio to ultrasound or bronchoscopy or ultrasound-bronchoscopy arms, and then the procedure related complications and clinical outcomes will be evaluated and compared between the groups. the procedures will be performed according to standardized practices following hospital guidelines.

Eligibility criteria:
inclusion criteria: * adult patients (over 18 years old), intubated, mechanically ventilated, and with an indication for a tracheostomy exclusion criteria: patients with contraindications for pdt: * short neck * tracheal deviation * difficult anatomy * previous neck surgery * cervical trauma or inability to perform neck extension * preference for surgical tracheostomy by the patient assistant team * patients unable to provide informed consent
potential use of brain network activation analysis to diagnose major depression

Conditions: Major Depressive Disorder

Summary: the investigators are doing this study to find out if they can use electroencephalographic (eeg) recordings, which measure brain waves, to predict response to antidepressant treatments, as well as to distinguish patients who have depression from those who do not. in particular the investigators want to test the usefulness of a new type of analysis of eeg recordings called brain network activation or bna. bna allows to identify patterns of activation in brain networks and to track their changes over time.


Eligibility criteria:
for patients with major depressive disorder inclusion criteria: * • male and female outpatients, aged 18-55 years * subjects meeting full criteria for the diagnosis of current major depressive disorder (mdd) without psychotic features, as determined by clinical evaluation and mood module of structured diagnostic interview (scid), completed by the study clinician. * ham-d17 score of 14 or higher * able to provide informed consent * right handed, normal (corrected) vision and normal hearing exclusion criteria: * • other primary diagnoses including major depressive disorder with psychotic features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia, attention deficit hyperactivity disorder (adhd). * substance use disorder (abuse or dependence with active use within the last 6 months). * significant sensory deficits such as deafness or blindness. * severe or unstable medical illness, including history of closed head injury resulting in loss of consciousness, seizure disorder; history of neurological disorders. * pregnant or nursing females who are not using an accepted method of contraception (birth control pill, iud, combination of barrier methods) * clinically significant abnormal laboratory values or electrocardiogram for healthy controls inclusion criteria: * males and females, aged 18-55 years * subjects who do not meet full criteria for any of the major psychiatric diagnosis including mdd, bipolar disorder, schizophrenia, substance abuse/dependence, attention deficit hyperactivity disorder (adhd), as determined by clinical evaluation and structured diagnostic interview, completed by the study clinician. * right handed, normal (corrected) vision and normal hearing exclusion criteria: * any current primary psychiatric, or medical condition determined to be clinically significant. * current use of psychotropics or any medication with clinically significant central nervous system effects.

Keywords: eeg biomarker major depressive disorder healthy control
abatacept for patients with covid-19 and respiratory distress

Conditions: COVID-19

Summary: this is a single-arm open label trial for hospitalized patients with covid-19 (coronavirus). the primary endpoint of the study is to assess the requirement for mechanical ventilation in patients who are admitted to the hospital with covid-19 infection and a pulse oxygen level \</= 93% on room air. the primary endpoint analysis will be performed using all enrolled patients.

patients with covid-19 who are admitted with respiratory distress will be considered for enrollment on this study. patients will be screened and then if they meet eligibility criteria will be enrolled. abatacept will be administered on day 1 at a dose of 10 mg/kg. patients will then be followed closely through 90 days post-treatment.

Eligibility criteria:
inclusion criteria: * must be at least 18 years old. * confirmed sars-cov-2 infection, confirmed by polymerase chain reaction (pcr) \</=4 days prior to enrollment * evidence of respiratory distress including spo2 \</=93% on room air. * radiographic evidence of pulmonary infiltrates. * ability to understand and the willingness to provide informed consent. exclusion criteria: * patients already intubated/mechanically ventilated at screening will not be eligible. * patients with uncontrolled severe bacterial or fungal infections at the time of enrollment. * patients with previously diagnosed autoimmune disorders or who were on immunosuppressive medications prior to developing covid-19 are not eligible * pregnant or breastfeeding

Keywords: coronavirus
accuracy of continuous glucose monitors during the perioperative period in youth with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: this study is assessing the accuracy of continuous glucose monitors during surgical procedures requiring anesthesia.

this study is an observational study design that includes collection of continuous glucose data and venous blood glucose data (from either an iv or fingerstick) from a blood glucose meter. all subjects will be undergoing a surgical procedure that requires anesthesia. the primary outcome of this study is to evaluate the accuracy of the cgm glucose values in comparison to the reference glucometer glucose value during anesthesia. there is currently limited data on accuracy of cgms during these events and therefore it is not know whether cgm glucose data is reliable to be used as the sole source of glucose monitoring during surgery.

Eligibility criteria:
inclusion criteria: 1. participants will be 2 to 26 years of age at the time of enrollment. 2. participants will have a diagnosis of type 1 diabetes on insulin therapy and requiring close glucose monitoring during the hospitalization and the perioperative period. 3. participant currently wearing a continuous glucose monitor (for example: dexcom g6 or g7; freestyle libre 2, 2 plus, or 3; medtronic guardian 3 or 4; or future sensors as they become available) for home diabetes management and willing to share personal cgm data with the bdc clinical cgm account. exclusion criteria: 1. pregnancy. 2. currently using hydroxyurea. 3. a condition that the investigator determines would prevent the patient from participation.

Keywords: anesthesia continuous glucose monitors accuracy pediatrics